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NCT Number: NCT05593146

A Randomized Controlled Study Evaluating Modified Cup Anteversion Placement in Prevention of Postoperative Dislocation in Patients Undergoing Acetabular Tumor Resection and Reconstruction

The purpose of this clinical study is to investigate whether patients who receive modified anteversion angle (( α-15°)±10°) of the acetabular cup have a lower risk of dislocation within one year after surgery, compared to patients who receive conventional anteversion angle ( α±10°) of the acetabular cup.

The hypothesis is that patients with placement of the modified (( α-15°)±10°) anteversion angle of the acetabular component will have decreased risk of dislocation 1 year after surgery compared to patients with conventional anteversion angle ( α±10°) placement.

PS: α refers to the preoperative anteversion angle of the affected hip. α equals to the anteversion angle of the contralateral limb if it cannot be accurately measured on the affected limb. A standard error within 10° is accepted

Recruiting

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Key information

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Ningbo No.6 Hospital

Ningbo, Zhejiang, 311200, China

Location status: Recruiting

About this study

Hip dislocation is a common complication in patients who undergo reconstruction surgery after periacetabular tumor resection and most of these cases are anterior dislocations. Studies suggest that this type of dislocation may be closely related to the position and anteversion angle of the acetabular component. Therefore, properly reducing the anteversion angle of the acetabular cup during reconstruction might effectively prevent possible collisions between the cup and the femoral component, thereby reducing the potential risk of dislocation. Based on this theory, we aim to investigate whether patients who receive modified anteversion angle (( α-15°)±10°) of the acetabular cup have a lower risk of dislocation within one year after surgery, compared to patients who receive conventional anteversion angle ( α±10°) of the acetabular cup.

PS: α refers to the preoperative anteversion angle of the affected hip. α equals to the anteversion angle of the contralateral limb if it cannot be accurately measured on the affected size. A standard error within 10° is accepted.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age above 16 years old, gender is not limited.
  • Tumor involving periacetabulum, femoral head, femoral neck or proximal femur
  • Patients require 3D-printed hemipelvic endoprosthetic reconstruction following periacetabular tumor resection
  • The subject has an estimated survival period of at least one year or more.
  • The subjects with informed consent

Exclusion criteria

  • The patient used to conduct surgery on his/her hip joint
  • The patient's current surgery aimed for hip revision for implant failure or infection
  • The patient didn't conduct hip endoprosthetic reconstruction
  • Patients with congenital defects in the gluteal muscle group, neurological function or pelvic tilt deformity severe enough to affect functional activity
  • Patients cannot self-assess postoperative function after surgery
  • According to the judgment of the investigator/supervisor, there may be difficulties in completing postoperative follow-up
  • Subjects have participated in similar research projects

Treatment and study plan

modified anteversion angle placement(( α-15°)±10°)

Behavioral

Preoperative examination was conducted to determine a safe surgical margin in all patients. A 3D printed osteotomy guide combined with a 3D printed prosthesis pre- designed anteversion angle is assembled for reconstruction after tumor resection.

Once completed, intraoperative X-ray fluoroscopy was applied to evaluate the anteversion angle of the acetabular component. If the anteversion angle doesn't meet the predetermined criteria, it needs to be adjusted until it does.

conventional anteversion angle placement ( α±10°)

Behavioral

Preoperative examination was conducted to determine a safe surgical margin in all patients. A 3D printed osteotomy guide combined with a 3D printed prosthesis with predesigned anteversion angle is assembled for reconstruction following tumor resection.

Once completed, intraoperative X-ray fluoroscopy was applied to evaluate the anteversion angle of the acetabular component. If the anteversion angle doesn't meet the predetermined criteria, it needs to be adjusted until it does.

Primary outcomes

  1. The endpoint for patient participation will dislocate

    Time frame: followed for 1 years postoperatively for study end points

    postoperative hip dislocation

Secondary outcomes

  1. MSTS score

    Time frame: followed 1 month, 3 months, 6 months, 9 months and 1 year postoperatively for study endpoints

    The Musculoskeletal Tumor Society (MSTS) scoring system is a validated and well-accepted functional scoring system used in orthopaedic oncology research

  2. TESS score

    Time frame: followed 1 month, 3 months, 6 months, 9 months and 1 year postoperatively for study endpoints

    Toronto Extremity Salvage Score (TESS) is a physical disability measure developed specifically for patients undergoing surgery for extremity tumours

  3. Henderson's failure mode

    Time frame: followed 1 month, 3 months, 6 months, 9 months and 1 year postoperatively for study endpoints

    1: soft tissue failure; 2: aseptic loosening; 3: structural failure; 4: periprosthetic infection; 5: tumor progression

Study contacts

Contact information is provided by the study sponsor or research team.

Hao Qu, MD

CONTACT

[email protected]

13666615399

Nong Lin, MD

CONTACT

[email protected]

13958195545

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

A Multi-center, Double-blinded, Randomized Controlled Study Comparing Modified Cup Anteversion vs Conventional Cup Anteversion Placement in Prevention of Postoperative Dislocation in Patients Undergoing Acetabular Tumor Resection and Reconstruction

Important dates

Study start
2023
Primary completion
2027
Study completion
2028
First posted
Oct 25, 2022
Registry last updated
Mar 6, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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